Therapeutic Area Head, Clinical Development

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* This position will be located on-site in Menlo Park, CA / Princeton, NJ / or Miami, FL

About Summit:

Ivonescimab, known as SMT
112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Overview of Role:

The Therapeutic Area Head, Clinical Development will be primarily responsible for developing and executing an integrated strategy and clinical trial program for a specific therapeutic area in oncology. Proposed areas include but are not limited to gastrointestinal (GI) oncology, breast oncology, head and neck oncology (HNSCC), and genitourinary oncology (GU).

The incumbent will be responsible for providing clinical expertise, obtaining scientific advisory input from external experts, working cross-functionally to develop clinical studies, supporting regulatory interactions for product advancement, and partnering with the operations team to provide advice and decision making regarding medical input to achieve operational excellence. The incumbent must be a recognized expert in a therapeutic area in oncology, have demonstrated effective collaborative skills to work across various phases of clinical development, and serve as a key medical expert for multiple cross functional teams.

Investigator engagement including travel to support face-to-face interaction and protocol training is a vital component of this role. Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in a fast-paced and intense environment.

The Therapeutic Area Head will serve as a leader on one or more potentially pivotal programs reporting directly into the Chief Medical Officer.

Role and Responsibilities:

• Significant oncology experience: the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients
• Established network and relationships with oncology experts, investigators and opinion leaders
• Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications
• Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals
• Lead teams to execute on clinical development…